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ISO 13485:2016 & 21 CFR 820 Purchase-To-Own Software
ISO 13485 & 21 CFR 820 Complete Software with all 15 Modules
Software with complete set of 15 modules: Document Library, Forms & Records, Document Control, Training, Change Control, Risk Management, Complaints, CAPAs, NC Product,
Products, Internal Audits, Management Reviews, Supplier Control, Mesuring Equipment, Preventive Maintenance
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Standard
Edition |
Professional
Edition |
| ISO 13485 & 21 CFR 820 IMSXpress software with 15 modules. Incl. 3 Full users |
$4,650 |
$6.200 |
| Pre-loaded ISO 13485:2016 & 21 CFR 820 template documentation: Quality Manual and 40 Operational Procedures (forms are embedded in the software, so no 'paper' forms are included) |
$760 (nonrefundable) |
| ISO 13485:2016 & 21 CFR 820 Internal Audit Checklist (can also use for Gap Analysis) |
$110 (nonrefundable) |
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Additional Users
Discounts available for 10 or more Full, Basic or Offline Trainee licenses
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Standard
Edition |
Professional
Edition |
Additional Full User account
(You can change quantity in the shopping cart)
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$516 |
$690 |
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Additional Basic User account
(You can change quantity in the shopping cart) |
$258 |
$345 |
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Additional Offline Trainee
account
(You can change quantity in the shopping cart)
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$86 |
$115 |
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Software Validation Report Package
The validation report package includes Validation Plan, Full Validation Report (about 600 pages), Software Release Notice, and Software Validation procedure. The documents are updated for new software versions.
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Software Validation Report Package: Validation Plan, Final Validation Report (over 600 pages), Software Release Notice, Software Validation operational procedure
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Annual |
$760/year |
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Database Hosting Service
Hostig your database on Microsoft Azure cloud server, plus backups and other maintenance.
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Database Hosting Service: Optional database cloud hosting with online access. Includes daily backups with 7 days retention.
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Annual |
$760/year |
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Maintenance & Technical Support Plan
The M&TS Plan includes updates and technical suppot.
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Maintenance & Technical Support Plan billed annually at 15% of the cost of your software and additional users, per current pricing
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Annual |
15% value |
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Upgrade Add-On Modules (for existing systems)
For systems that were purchased before these new modules existed
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Standard
Edition |
Professional
Edition |
Training module:
Fully automated training system with self e-training, integrated document training, job descriptions, and more (Full, Basic or Offline Trainee license is required for each trainee) |
$750 |
$1,000 |
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Change Control module:
Use for document, engineering, and process
changes. Fully integrated with Doc Control module. |
$750 |
$1,000 |
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Risk Management module:
Use for ISO 14971 device risk management
and to manage QMS related risks. |
$750 |
$1,000 |
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Forms/Records module:
Use for making fillable PDF form templates, and for filling the forms with data and creating records. |
$750 |
$1,000 |
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Preventive Maintenance module:
Use for scheduling and administrating maintenance,
and for managing spare parts inventory |
$750 |
$1,000 |
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Products module:
For each product (device) track changes, CPAs, complaints, nonconformities, risk management, audit findings, and supplier nonconformities |
$750 |
$1,000 |
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Software Edition Upgrades (for existing systems)
Upgrades are easy to install and completely preserve your data continuity
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Software
Upgrade |
Full User
Upgrade |
Basic user
Upgrade |
From: STANDARD edition
To: PROFESSIONAL edition |
$1,860 |
$200/user |
$100/user |
From: LIGHT edition
To: STANDARD edition w/ 3 Full User licenses |
$1,320 |
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From: LIGHT edition
To: PROFESSIONAL edition w/ 3 Full User licenses |
$2,970 |
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Maintenance & Technical Support Plan
Software updates and technical support
For-purchase-to-own software the first year Maintenance & Technical Support plan is included in the initial purchase
price. After the first year you need to purchase the annual Maintenance &
Technical Support plan at 15% of the cost of your software and additional users, per current pricing above.
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If you require a quote, please contact us by phone +1 626 796 9000 or email cs@imsxp.com
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Remote Online Access
Optional database cloud hosting and maintenance can be purchased as an ad-on service.
Maintenance and
Technical Support
First year Maintenance & Technical Support plan is included in the initial purchase
price. After the first year you need to purchase a Maintenance and Technical
Support plan (to see pricing, scroll down to the bottom of page).
The differences between the Standard and Professional editions are shown in the Feature Chart.
The template documentation package
and the internal audit checklist are not refundable.
Note:
When you are upgrading from Standard to Professional edition, you need to purchase 'User Upgrade' for the total number of users in your
current system. You can adjust the number of users in the shopping cart.
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